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Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

Primary Purpose

Pneumococcal Disease

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
13vPnC
PPSV23
20vPnC
Sponsored by
Pfizer
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pneumococcal Disease

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria

  1. Male or female adults 65 years of age or greater.
  2. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product.
  3. Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception.

  4. Male or female adults who meet 1 of the following:

    1. Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to 5 years prior to vaccination in the study, and no prior 13vPnC vaccination (Cohort A).
    2. Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B).
    3. Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C).

Exclusion Criteria

  1. Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study.
  2. History of microbiologically proven invasive disease caused by S pneumoniae.

Sites / Locations

  • Coastal Clinical Research, Inc.
  • East Valley Gastroenterology and Hepatology Associates
  • The Pain Center of Arizona
  • HOPE Research Institute
  • The Pain Center of Arizona
  • Anaheim Clinical Trials, LLC
  • Diablo Clinical Research, Inc.
  • Clinical Research Consulting, LLC
  • Optimal Research, LLC
  • Synexus Clinical Research US, Inc
  • Meridian Clinical Research, LLC
  • Clinical Research Atlanta
  • East-West Medical Research Institute
  • Heartland Research Associates, LLC
  • Heartland Research Associates, LLC
  • MedPharmics, LLC
  • Meridian Clinical Research, LLC
  • Meridian Clinical Research, LLC
  • MedPharmics, LLC
  • Carolina Institute for Clinical Research
  • PMG Research of Wilmington, LLC
  • CTI Clinical Research Center
  • Sterling Research Group, Ltd.
  • Prestige Clinical Research
  • Lynn Health Science Institute
  • Kaiser Permanente Center For Health Research
  • Columbia Research Group, Inc.
  • Medical Research South, LLC
  • Ventavia Research Group
  • J. Lewis Research Inc. / Foothill Family Clinic Draper
  • J. Lewis Research, Inc. - Foothill Family Clinic
  • J. Lewis Research, Inc. / Foothill Family Clinic South
  • J. Lewis Research, Inc. / Jordan River Family Medicine
  • Kaiser Permanente Washington Health Research Institute
  • PharmaSite
  • Ladulaas Kliniska Studier
  • Infektionskliniken
  • CTC Gothia Forum
  • ProbarE i Lund
  • Avdelningen for Kliniska Provningar
  • Karolinska Trial Alliance, KTA Prim
  • Akardo Med Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Experimental

Arm Label

13vPnC

PPSV23

20vPnC

Arm Description

Pneumococcal conjugate vaccine

Pneumococcal polysaccharide vaccine

Pneumococcal conjugate vaccine

Outcomes

Primary Outcome Measures

Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.

Secondary Outcome Measures

Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.

Full Information

First Posted
February 7, 2019
Last Updated
February 2, 2021
Sponsor
Pfizer
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1. Study Identification

Unique Protocol Identification Number
NCT03835975
Brief Title
Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination
Official Title
A PHASE 3, RANDOMIZED, OPEN-LABEL TRIAL TO EVALUATE THE SAFETY AND IMMUNOGENICITY OF A 20-VALENT PNEUMOCOCCAL CONJUGATE VACCINE IN ADULTS ≥65 YEARS OF AGE WITH PRIOR PNEUMOCOCCAL VACCINATION
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
February 12, 2019 (Actual)
Primary Completion Date
February 12, 2020 (Actual)
Study Completion Date
February 12, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Pfizer

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This Phase 3 will describe the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine formulation in adults 65 years of age or older with prior pneumococcal vaccination

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumococcal Disease

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
875 (Actual)

8. Arms, Groups, and Interventions

Arm Title
13vPnC
Arm Type
Active Comparator
Arm Description
Pneumococcal conjugate vaccine
Arm Title
PPSV23
Arm Type
Active Comparator
Arm Description
Pneumococcal polysaccharide vaccine
Arm Title
20vPnC
Arm Type
Experimental
Arm Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
13vPnC
Intervention Description
Pneumococcal conjugate vaccine
Intervention Type
Biological
Intervention Name(s)
PPSV23
Intervention Description
Pneumococcal polysaccharide vaccine
Intervention Type
Biological
Intervention Name(s)
20vPnC
Intervention Description
Pneumococcal conjugate vaccine
Primary Outcome Measure Information:
Title
Percentage of Participants With Local Reactions Within 10 Days After Vaccination
Description
Local reactions were recorded using an electronic diary (e-diary). Local reactions included redness, swelling and pain at the injection site. Redness and swelling were measured and recorded in measuring device units. 1 measuring device unit =0.5 centimeter (cm). Redness and swelling were graded as mild (greater than [>] 2.0 to 5.0 cm), moderate (>5.0 to 10.0 cm) and severe (>10.0 cm). Pain at injection site was graded as mild (did not interfere with activity), moderate (interfered with activity), and severe (prevented daily activity).
Time Frame
Within 10 days after vaccination
Title
Percentage of Participants With Systemic Events Within 7 Days After Vaccination
Description
Systemic events fever, fatigue, headache, muscle pain and joint pain were recorded by using an e-diary. Fever was defined as temperature >=38.0 degree Celsius (C) and categorized to >=38.0 to 38.4 degree C, >38.4 to 38.9 degree C, >38.9 to 40.0 degree C and >40.0 degree C. Fatigue, headache, muscle pain and joint pain were graded as mild (did not interfere with activity), moderate (some interference with activity) and severe (prevented daily routine activity).
Time Frame
Within 7 days after vaccination
Title
Percentage of Participants With Adverse Events (AEs) Within 1 Month After Vaccination
Description
An AE was any untoward medical occurrence in study participants who received study vaccine without regard to possibility of causal relationship with the treatment.
Time Frame
Within 1 month after vaccination
Title
Percentage of Participants With Serious Adverse Events (SAEs) Within 6 Months After Vaccination
Description
An SAE was any untoward medical occurrence at any dose that results in death; is life-threatening (immediate risk of death); requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant disability/incapacity (substantial disruption of the ability to conduct normal life functions); results in congenital anomaly/birth defect or that is considered to be an important medical event.
Time Frame
Within 6 months after vaccination
Title
Percentage of Participants With Newly Diagnosed Chronic Medical Conditions (NDCMCs) Within 6 Months After Vaccination
Description
An NDCMC was defined as a disease or medical condition, not previously identified, that was expected to be persistent or was otherwise long-lasting in its effects.
Time Frame
Within 6 months after vaccination
Title
Pneumococcal Opsonophagocytic Activity (OPA) Geometric Mean Titers (GMTs) at 1 Month After Vaccination
Description
OPA GMTs were determined for serotypes: 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F. OPA titer was expressed as reciprocal of the highest serum dilution.
Time Frame
1 month after vaccination
Secondary Outcome Measure Information:
Title
Pneumococcal OPA Geometric Mean Fold Rise (GMFR) From Before Vaccination to 1 Month After Vaccination
Description
OPA GMFR is the ratio of OPA GMTs, 1 month after vaccination to before vaccination. OPA GMFRs from before to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame
From before vaccination to 1 month after vaccination
Title
Percentage of Participants With >=4-Fold Rise in Pneumococcal OPA Titers From Before Vaccination to 1 Month After Vaccination
Description
Percentage of participants with a >=4-fold rise in pneumococcal OPA titers from before vaccination to 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame
From before vaccination to 1 month after vaccination
Title
Percentage of Participants With Pneumococcal OPA Titers >=Lower Limit of Quantitation (LLOQ) at 1 Month After Vaccination
Description
The percentage of participants with OPA titers >=LLOQ at 1 month after vaccination were calculated for pneumococcal serotypes 1, 3, 4, 5, 6A, 6B, 7F, 9V, 14, 18C, 19A, 19F, 23F, 8, 10A, 11A, 12F, 15B, 22F and 33F.
Time Frame
1 month after vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria Male or female adults 65 years of age or greater. Adults determined by clinical assessment, including medical history and clinical judgment, to be eligible for the study, including adults with preexisting stable disease, defined as disease not requiring significant change in therapy in the previous 6 weeks or hospitalization for worsening disease within 12 weeks before receipt of investigational product. Female subject of nonchildbearing potential; male subject not able to father children or who is able to father children and willing to use a highly effective method of contraception. Male or female adults who meet 1 of the following: Vaccination with PPSV23 greater than or equal to 1 year and less than or equal to 5 years prior to vaccination in the study, and no prior 13vPnC vaccination (Cohort A). Vaccination with 13vPnC greater than or equal to 6 months prior to vaccination in the study, and no prior PPSV23 vaccination (Cohort B). Vaccination with 13vPnC followed by PPSV23 (PPSV23 vaccination greater than or equal to 1 year prior to vaccination in the study) (Cohort C). Exclusion Criteria Serious chronic disorder including metastatic malignancy, severe chronic obstructive pulmonary disease (COPD) requiring supplemental oxygen, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, or any other disorder that, in the investigator's opinion, excludes the subject from participating in the study. History of microbiologically proven invasive disease caused by S pneumoniae.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pfizer CT.gov Call Center
Organizational Affiliation
Pfizer
Official's Role
Study Director
Facility Information:
Facility Name
Coastal Clinical Research, Inc.
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36608
Country
United States
Facility Name
East Valley Gastroenterology and Hepatology Associates
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
The Pain Center of Arizona
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
HOPE Research Institute
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
The Pain Center of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Anaheim Clinical Trials, LLC
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Diablo Clinical Research, Inc.
City
Walnut Creek
State/Province
California
ZIP/Postal Code
94598
Country
United States
Facility Name
Clinical Research Consulting, LLC
City
Milford
State/Province
Connecticut
ZIP/Postal Code
06460
Country
United States
Facility Name
Optimal Research, LLC
City
Melbourne
State/Province
Florida
ZIP/Postal Code
32934
Country
United States
Facility Name
Synexus Clinical Research US, Inc
City
The Villages
State/Province
Florida
ZIP/Postal Code
32162
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Savannah
State/Province
Georgia
ZIP/Postal Code
31406
Country
United States
Facility Name
Clinical Research Atlanta
City
Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
Country
United States
Facility Name
East-West Medical Research Institute
City
Honolulu
State/Province
Hawaii
ZIP/Postal Code
96814
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Heartland Research Associates, LLC
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
MedPharmics, LLC
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20854
Country
United States
Facility Name
Meridian Clinical Research, LLC
City
Norfolk
State/Province
Nebraska
ZIP/Postal Code
68701
Country
United States
Facility Name
MedPharmics, LLC
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87102
Country
United States
Facility Name
Carolina Institute for Clinical Research
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
PMG Research of Wilmington, LLC
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
CTI Clinical Research Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45212
Country
United States
Facility Name
Sterling Research Group, Ltd.
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45246
Country
United States
Facility Name
Prestige Clinical Research
City
Franklin
State/Province
Ohio
ZIP/Postal Code
45005
Country
United States
Facility Name
Lynn Health Science Institute
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73112
Country
United States
Facility Name
Kaiser Permanente Center For Health Research
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227
Country
United States
Facility Name
Columbia Research Group, Inc.
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Medical Research South, LLC
City
Goose Creek
State/Province
South Carolina
ZIP/Postal Code
29445
Country
United States
Facility Name
Ventavia Research Group
City
Keller
State/Province
Texas
ZIP/Postal Code
76248
Country
United States
Facility Name
J. Lewis Research Inc. / Foothill Family Clinic Draper
City
Draper
State/Province
Utah
ZIP/Postal Code
84020
Country
United States
Facility Name
J. Lewis Research, Inc. - Foothill Family Clinic
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84109
Country
United States
Facility Name
J. Lewis Research, Inc. / Foothill Family Clinic South
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84121
Country
United States
Facility Name
J. Lewis Research, Inc. / Jordan River Family Medicine
City
South Jordan
State/Province
Utah
ZIP/Postal Code
84095
Country
United States
Facility Name
Kaiser Permanente Washington Health Research Institute
City
Seattle
State/Province
Washington
ZIP/Postal Code
98101
Country
United States
Facility Name
PharmaSite
City
Malmo
State/Province
Skane
ZIP/Postal Code
21152
Country
Sweden
Facility Name
Ladulaas Kliniska Studier
City
Boras
ZIP/Postal Code
50630
Country
Sweden
Facility Name
Infektionskliniken
City
Eskilstuna
ZIP/Postal Code
63188
Country
Sweden
Facility Name
CTC Gothia Forum
City
Goteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
ProbarE i Lund
City
Lund
ZIP/Postal Code
22222
Country
Sweden
Facility Name
Avdelningen for Kliniska Provningar
City
Orebro
ZIP/Postal Code
703 62
Country
Sweden
Facility Name
Karolinska Trial Alliance, KTA Prim
City
Stockholm
ZIP/Postal Code
11361
Country
Sweden
Facility Name
Akardo Med Site
City
Stockholm
ZIP/Postal Code
11446
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
IPD Sharing URL
https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests
Citations:
PubMed Identifier
34839993
Citation
Cannon K, Elder C, Young M, Scott DA, Scully IL, Baugher G, Peng Y, Jansen KU, Gruber WC, Watson W. A trial to evaluate the safety and immunogenicity of a 20-valent pneumococcal conjugate vaccine in populations of adults >/=65 years of age with different prior pneumococcal vaccination. Vaccine. 2021 Dec 17;39(51):7494-7502. doi: 10.1016/j.vaccine.2021.10.032. Epub 2021 Nov 25.
Results Reference
derived
Links:
URL
https://pmiform.com/clinical-trial-info-request?StudyID=B7471006
Description
To obtain contact information for a study center near you, click here.

Learn more about this trial

Trial to Evaluate the Safety and Immunogenicity of a 20-Valent Pneumococcal Vaccine in Adults 65 Years of Age or Older With Prior Pneumococcal Vaccination

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